Regulatory Affairs

When the Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR) took effect. QMSR amended 21 CFR 820 with a framework aligned to ISO 13485:2016. Buried in that shift is a quieter change, one that matters enormously if you're developing medical devices for both the US and Europe. Usability engineering stopped being two separate conversations.

Sarah Shen's fever-alert patch had a working prototype and a standing ovation. Then one question about software classification revealed the foundations were missing, and rebuilds cost three to five times more.